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  • 1.  Combination Products with Multiple Drug Substances (DS)

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jan-2020 17:28
    This message was posted by a user wishing to remain anonymous

    Firstly, thank you for the inputs. I am looking for advice or case studies on products submitted as INDs to CDER/CBER with multiple drug substance (DS) sections. When might this strategy be appropriate?

    For drug-device/biologic/device combo products, would it be appropriate to include a device as a seperate secondary DS for combinations involving both in the final combination product where the device/biologic and small molecule contribute to the therapeutic effect. Delivery pens/injectors/autoinjectors are commonly container-closure & secondary container-closure, but how about microneedle, patch, cell containment devices, etc. How would you treat these (container closure vs. DS).  What are the pros/cons of having the device as a container-closure vs DS?


  • 2.  RE: Combination Products with Multiple Drug Substances (DS)

    Posted 03-Jan-2020 07:25

    I am not sure I understand your question, but I fail to see how any device, whether part of the container closure system or not could be considered a drug substance.  These are all components of the Drug Product, or if provided as a separate device, a finished medical device (usually in Module 3, likely in the regional section).  Even the primary containers are part of the drug Product in module 3. 

     

    I do not understand how these are drug substances.  Perhaps you can clarify.

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


  • 3.  RE: Combination Products with Multiple Drug Substances (DS)

    Posted 03-Jan-2020 08:21
    In general I agree with Lee, device CPs with drug PMOA (typically injectors/applicators) are considered part of the primary container/container closure and always filed with drug product.

    The only instance in which I could see potentially including the "device" in the DS section would be if the device itself has an additional chemical MOA (e.g. bioresorbable microneedles) that somehow enhance the activity of the primary MOA moiety (e.g. greater than that of a standard injector) in which case the chemistry of the microneedles might be discussed in a DS section? In any case, if you are confused or uncertain this is a situation in which I would include a question about filing structure in a pre-IND meeting request should you do one.

    ------------------------------
    Krystin Meidell MS
    Manager, Regulatory Affairs CMC Combination Products
    Boston MA
    United States
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    Original Message


  • 4.  RE: Combination Products with Multiple Drug Substances (DS)

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jan-2020 09:18
    This message was posted by a user wishing to remain anonymous

    I am not quite sure if I understood your question. A fixed dose combination, which is a drug product which has multiple drug substances, is not a combination product per definition. A combination product includes two of a drug, biologic, and and/or a device. A device is not a drug substance. If it has a therapeutic effect,  you would write it up as a device application. 

    If you are not sure of the primary mode of action, or you think it is both, but you should seek input from the FDA Office Combination products who will tell you how it is regulated.
    Original Message


  • 5.  RE: Combination Products with Multiple Drug Substances (DS)

    Posted 07-Jan-2020 03:59
    Hi,

    Drug product with more than one DS, would be considered regular product except that you need to provide DS related information for both DS separately.

    Regarding combination products of drug-device, patch, microneedle are generally considered in CCS​. These could be considered in DS, based on mode of action. Sorry no experience with me. You could also discuss in Pre-IND meeting.

    ------------------------------
    Deepa Dasgupta RAC
    Director
    Hyderabad
    India
    ------------------------------

    Original Message


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